This study will be a multicentre randomized controlled trial to assess the efficacy between balloon dilatation and self-expanding metallic stent placement for endoscopic treatment of stenosis in Crohn´s Disease.
A Prospective, randomized, multicenter clinical trial. Duration: Beginning in mid-2013 with a minimum of three years depending on the patient inclusion rate. The participation of at least 20 hospitals in Spain with an inclusion of about 6 patients per hospital is required. Calculation of sample size: The calculation of sample size was performed considering that the efficacy of endoscopic treatment by endoscopic stent placement is superior to endoscopic dilatation: 75% vs 50% for balloon dilation (% of patients free of therapeutic intervention -endoscopic or surgically a year follow-up). For all 61 patients are required for each treatment group, the total of 122 patients. This calculation is made taking into account: * Bilateral Contrast: any two samples may be superior in terms of efficacy. * Error type I: 0.05 * Error type II: 0.20 (statistical power 80%) * Percentage of efficacy at one year follow-up: 75% in the prosthetic group and 50% in the balloon dilatation group * Percentage of losses: 5%. Schedule 1. Screening Visit 2. Sheet Inclusion 3. Expansion notebook / prosthesis placement notebook 4. Monitoring Worksheet to the 7 days. Symptomatic / complications-incidents assessment. 5. Monitoring Worksheet to the 30 days. Symptomatic / complications-incidents assessment. Includes analytical. In case of placement of prostheses include prosthetic removal sheet 6. Monitoring Worksheet to the 2 months. Symptomatic / complications-incidents assessment. 7. Monitoring Worksheet to the 3 months. Symptomatic / complications-incidents assessment. 8. Monitoring Worksheet to the 4 months. Symptomatic / complications-incidents assessment 9. Monitoring Worksheet to the 5 months. Symptomatic / complications-incidents assessment 10. Monitoring Worksheet to the 6 months. Symptomatic / complications-incidents assessment. Include analytical 11. Monitoring Worksheet to the 7 months. Symptomatic / complications-incidents assessment 12. Monitoring Worksheet to the 8 months. Symptomatic / complications-incidents assessment 13. Monitoring Worksheet to the 9 months. Symptomatic / complications-incidents assessment 14. Monitoring Worksheet to the 10 months. Symptomatic / complications-incidents assessment 15. Monitoring Worksheet to the 11 months. Symptomatic / complications-incidents assessment 16. Monitoring Worksheet to the 12 months. Symptomatic / complications-incidents assessment Include analytical. 17. Final assessment. 18. Monitoring Worksheet to the recurrence. Symptomatic / complications-incidents assessment. Include analytical
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
* Income on short stay unit (SSU) post-procedure * Light sedation by the endoscopist vs anesthetist by center * Fully covered self-expanding metal stents Tae Woong Medical® type; prosthesis size at the endoscopist discretion * Clips can be placed at the distal end of the prosthesis according to the endoscopist. * Prosthesis removal time in 4 weeks.
* Income on short stay unit (SSU) post-procedure * Light sedation by the endoscopist vs anesthetist by center. * Pneumatic ball type CRE Boston cientific®; balloon diameter at the endoscopist discretion * Up to 2 expansion will be made with a minimum interval between 15-30 days between each expansion * It shall be deemed failure to expansion if required\> 2 expansions.
Hospital Unversitari Mutua de Terrasa
Terrassa, Barcelona, Spain
RECRUITINGPercentage (%) of free patients of therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at one year follow-up
To evaluate the efficacy of endoscopic treatment (prosthesis vs dilation), determined by the percentage of free patients of a new therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at one year follow-up. Symptomatic recurrence assessment: It will be performed through an obstructive symptoms scale previously described (Attar et al, Safety and efficacy of extractible self-expandable metal stents in the treatment of Crohn's disease intestinal strictures: A prospective pilot study. Inflamm Bowel Dis. 2011 Dec 11).
Time frame: one year follow-up
Percentage of free patients of therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at 6 months follow-up.
To evaluate the efficacy of endoscopic treatment (prosthesis vs dilation), determined by the percentage of patients free of therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at 6 months follow-up. Symptomatic recurrence assessment: It will be performed through an obstructive symptoms scale previously described (Attar et al, Safety and efficacy of extractible self-expandable metal stents in the treatment of Crohn's disease intestinal strictures: A prospective pilot study. Inflamm Bowel Dis. 2011 Dec 11).
Time frame: At 6 months follow-up
Rate of complications related to the procedure.
Evaluate the safety and complications of both treatments Immediate complications related to the procedure: * None * Inhaled into the lungs. * Respiratory depression O2 Sat \<90% * Cardiorespiratory arrest * Arrhythmia * Allergic reaction * Pain * Hemorrhage: self-limiting (spontaneous hemostasis) / accurate endoscopic treatment (drooling bleeding / bleeding jet). * Piercing: endoscopic treatment / surgery treatment * Exitus * Others Late complications related to the procedure: * Pain * Hemorrhage: self-limiting (spontaneous hemostasis) / accurate endoscopic treatment (drooling bleeding / bleeding jet). * Piercing: endoscopic treatment / surgery treatment * Exitus * Others
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Time frame: one year follow-up
The procedure total costs
Evaluate the costs of both treatments Study costs: The calculate procedure of diagnostic test (DT) cost is composed of some premises: * Calculate the test unit cost * Accounting for all costs associated with DT Direct and Indirect Costs
Time frame: one year follow-up